Label: HAND SANITIZER liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 14, 2020

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  • DOSAGE & ADMINISTRATION

    Store between 15-30°C(59-86°F)

    Avoid feezing and excessive heat above40°C (104°F)

  • INACTIVE INGREDIENT

    Water

    Glycerin

    Hydrogen Peroxide

    Tert-butyl alcohol

    Denatonium benzoate

  • INDICATIONS & USAGE

    Place enough product on hands to cover all surfaces.Rub hands together until dry.

  • ACTIVE INGREDIENT

    Ethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    For external use only.Flammable. Keep away from heat or flame.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55467-006
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL200 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code GERMSMASH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55467-006-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/04/2020
    Labeler - INTENTLY (GUANGZHOU) BIOTECHNOLOGY CO., LTD. (554531968)
    Establishment
    NameAddressID/FEIBusiness Operations
    INTENTLY (GUANGZHOU) BIOTECHNOLOGY CO., LTD.554531968manufacture(55467-006)
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